MAUDE Adverse Event Report: HILL-ROM BATESVILLE VERSACARE FRAME; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number P3200K000613

Device Problem Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Date 12/30/2020

Event Type  malfunction  

Manufacturer Narrative

The hillrom technician found the pin housing on the side communication cable was missing, and the side communication cable needed to be replaced since it had damaged and missing pins.Per hillrom¿s health hazard evaluation: during usage the pins from the port connected to the facility wall side may become damaged (broken, bent etc.).The primary root cause for this is that the communication cable is not properly removed from the wall and secured to the bed frame before transporting the bed.When the communication cable is pulled from the wall at an angle there is a potential for the pins/connector to get damaged.This is an inherent product use case issue (potential misuse) and not a product failure to meet the specified performance requirements.Nurse call systems in accordance with ul 1069 requires that the nurse call function be supervised, meaning that if for any reason the circuit is interrupted a nurse call or trouble signal is sent to the nurse¿s station.What this means is that there is no way for a sidecom® communication cable to have a bent pin, broken wire or other issue in the nurse call circuit without the facility staff having knowledge without prior cancellation of a nurse call.The versacare user manual has the following caution/warning notice: before transporting the bed, make sure that the power cord, hoses, and other equipment are properly stowed.Failure to do so could result in equipment damage.Make sure the patient, equipment, and all lines are securely placed within the perimeter of the bed for intra-hospital transport.After transport, make sure that the nurse call system cables are properly connected.A search of the hillrom maintenance records did not show hillrom performed any preventative maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.The technician replaced the side communication cable to resolve the issue.Based on this information, no further action is required.

Event Description

Hillrom received a report from a hillrom technician stating the bed had a note on it stating the nurse cable was not working.The bed was located at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: VERSACARE FRAME
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: lori daulton ; 1069 state route 46 east; batesville, IN 47006 ; 8129312280
• MDR Report Key: 11136680
• MDR Text Key: 227080899
• Report Number: 1824206-2021-00008
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: P3200K000613
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/30/2020
• Initial Date FDA Received: 01/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1